US20090112238A1 - Fistula brush device - Google Patents

Abstract

A medical device includes an elongate member extending between a first end portion and a second end portion and a brush disposed upon the elongate member between the first end portion and the second end portion. A first aperture is disposed proximate the first end portion and a second aperture disposed proximate the second end portion. A first suture is disposed through the first aperture and tied upon itself to form a first loop, and a second suture is disposed through the second aperture and tied upon itself to form a second loop, wherein each of the first loop and the second loop are configured to receive an implantable material.

Description

BACKGROUND
• A variety of fistulae are known to occur in humans and other mammals. These fistulae can occur for a number of reasons, such as but not limited to, congenital defects, as a result of an inflammatory bowel disease, such as Chron's disease, irradiation, trauma, childbirth, or as a side effect of a surgical procedure. Further several different types of fistulae can occur, for example, urethra-vaginal fistulae, vesico-vaginal fistulae, tracheo-esophageal fistulae, gastro-cutaneous fistulae, and any number of anorectal fistulae, such as recto-vaginal fistulae, recto-vesical fistulae, recto-urethral fistulae, or recto-prostatic fistulae.
• The field of the invention is that of medical and surgical instruments, and in particular, medical and surgical instruments intended primarily for minimally-invasive procedures such as procedures to correct various types of fistulae.
BRIEF SUMMARY
• The first aspect of the present invention provides a medical device. The medical device includes an elongate member extending between a first end portion and a second end portion and a brush disposed upon the elongate member between the first end portion and the second end portion. A first aperture is disposed proximate the first end portion and a second aperture is disposed proximate the second end portion. A first suture is disposed through the first aperture and tied upon itself to form a first loop, and a second suture is disposed through the second aperture and tied upon itself to form a second loop, wherein each of the first loop and the second loop are configured to receive an implantable material.
• A second aspect of the present invention provides a medical device. The medical device includes an elongate member extending between a first end portion and a second end portion, the elongate member defining a lumen through at least a portion thereof. A brush is disposed upon the elongate member between the first end portion and the second end portion. A first aperture is defined in the first end portion and a second aperture is defined in the second end portion. A first suture is disposed through the first aperture and tied to itself to define a first loop and a second suture disposed through the second aperture and tied to itself to define a second loop, wherein each of the first and second loops are configured to receive an implantable material.
• Advantages of the present invention will become more apparent to those skilled in the art from the following description of the preferred embodiments of the invention that have been shown and described by way of illustration. As will be realized, the invention is capable of other and different embodiments, and its details are capable of modification in various respects. Accordingly, the drawings and description are to be regarded as illustrative in nature and not as restrictive.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a perspective view of an elongate device configured to debride a fistula and insert an implantable material therein.
• FIG. 2 is a side view of another elongate device configured to debride a fistula and insert an implantable material therein.
• FIG. 3 is a side view of a modified device ofFIG. 2.
• FIG. 4 is the device ofFIG. 2 with an implantable device installed thereupon.
• FIG. 5 is a perspective view of an implantable material for use with the elongate device.
DETAILED DESCRIPTION OF THE DRAWINGS AND THE PREFERRED EMBODIMENTS
• Turning now to the embodiments shown inFIGS. 1-5, a device10 for treating and repairing fistulae is provided. The device10 includes first and secondelongate members21,22 and a brush portion40 that is engaged to aproximal end27,28 of each of the first and secondelongate members21,22. The brush portion40 includes a plurality ofbristles42 that extend radially from awire43, which extend along the length of the brush portion40. The plurality ofbristles42 may be disposed upon thewire43 in a plurality of clumps42athat are each disposed along a portion of the length of thewire43.
• The plurality of clumps42aeach include a plurality ofbristles42 that extend radially from substantially the same point of thewire43, withsufficient bristles42 provided such thatbristles42 extend from thewire43 in substantially every radial direction along the outer circumference of that portion of thewire43. In some embodiments, the brush portion40 may include between about 6 and about 12 clumps42aofbristles42. In some embodiments, the brush portion40 may include 6, 8, 10, 12 or another number of clumps42aofbristles42 along a portion of the length of thewire43. The clumps42amay be substantially evenly spaced between neighboring clumps42aalong a portion of the length of the wire40 or the clumps42amay be spaced at varying distances from neighboring clumps42aalong the length of a portion of the wire40.
• As shown inFIG. 1, thewire43 may be a single wire that extends between afirst end44 and a second end45 and receives the plurality ofbristles42 within a central portion46 of thewire43. In other embodiments shown inFIGS. 2-4, thewire43 may be formed from a plurality of wires43bthat are woven or otherwise engaged together to form a single member.
• In other embodiments shown inFIGS. 2-4, abrush portion140 is provided on the device10 and includes a plurality ofbristles142 that are retained by a plurality of discrete wires143bwoven or otherwise fixed together to form a bundle ofwires143. In other embodiments the three or more discrete wires143bmay be woven or otherwise engaged together to form the bundle ofwires143. In embodiments where two or more wires143bare woven together to form the bundle ofwires143, the plurality ofbristles142 are retained upon the bundle ofwires143 with a proximal end of eachbristle142 being retained between the neighboring wires143band retained thereupon due to the tightly woven nature of the multiple wires143b.
• In some embodiments and as shown inFIG. 4, the plurality ofbristles142 may be each formed with a first portion142cand a second portion142d, wherein the first and second portions142c,142deach extend radially from the bundle ofwires143. Thebristles142 each additionally include acentral portion142ebetween the first and second portions142c,142dthat is retained between neighboring wires143b. With thecentral portion142eretained by the bundle ofwires143, the first and second portions142c,142dextend radially from the bundle ofwires143 in opposing or different directions. In some embodiments,several bristles142 are retained at substantially the same position along the length of the bundle ofwires143 such that the first and second ends142c,142dof eachbristle142 extends radially from substantially the same position along the length of the bundle ofwires143 to form a clump142aofbristles142. Similar to the embodiments discussed above, thebrush portion140 may include a plurality of clumps142aofbristles142, such as between 6 and 12 clumps142aofbristles142. In someembodiments 6, 8, 10, 12 or other numbers of clumps142aofbristles142 may be disposed along the length of thebrush portion140.
• The first and secondelongate members21,22 are each configured with an extendeddistal end23,24 and aproximal end27,28. Theelongate members21,22 each additionally include alumen29 defined through at least a portion of theelongate member21,22. In some embodiments, thelumen29 extends to a position proximate thedistal end23,24 along the length of theelongate member21,22 to aproximal end27,28 of eachelongate member21,22. Specifically, thelumen29 in eachelongate member21,22 allows for fluid or gaseous communication from theproximal end27,28 of eachelongate member21,22 to a location proximate thedistal end23,24 of eachelongate member21,22.
• Theproximal end27,28 includes an aperture27a,28adefined within the end surface of the respectiveproximal end27,28. The apertures27a,28aare each configured to receive one of the first orsecond ends44,45 (or inother embodiments144,145) of the brush portion40 (140) therein to fix the brush portion40 (140) to the respectiveelongate member21,22. Specifically, thelumen29 and respective aperture27a,28amay have an inner diameter slightly larger than the outer diameter of the first andsecond ends44,45 (144,145) of the brush portion40 (140). The first andsecond ends44,45 (144,145) may be retained within the respective first and second apertures27a,28awith an adhesive, such as cyanoacrylate. In other embodiments, thelumen29 and the first and second apertures27a,28ahave an inner diameter that is substantially the same as the outer diameter of the first andsecond ends44,45 (144,145) of the brush portion40 (140) to allow the respective first andsecond end44,45 (144,145) to be retained within thelumen29 to rigidly connect the brush portion40 (140) to the first and secondelongate members21,22.
• In some embodiments, the first and secondelongate members21,22 may be made from a substantially flexible and compliant material such as nylon or other types of relatively soft plastic. Similarly, the wire43 (or bundle of wires143) may be made from a much harder and less compliant material such as stainless steel. In these embodiments, the wire43 (or bundle of wires143) may be formed with a slightly larger outer diameter than the inner diameter of the apertures27a,28aand thelumen29 of the first and secondelongate members21,22. Accordingly, when one of the first orsecond ends44,45 (144,145) of the brush portion40 (140) is inserted into the respective aperture27a,28a, the end of the brush portion40 (140) causes the respectiveelongate member21,22 to slightly deform to accept the slightlylarger end44,45 (144,145) of the brush portion40 (140). The slight deformation of theelongate member21,22 increases the strength of the connection between the brush portion40 (140) and theelongate members21,22, which increases the overall strength of the device10.
• The first andsecond members21,22 are each made from a relatively flexible material, which allows the first andsecond members21,22 to each be elastically deformed by the user to allow the device10 to be inserted into the patient as discussed below.
• In some embodiments shown inFIG. 3, thelumen29 may extend the length of eachelongate member21,22 between an aperture23a,24aon the respectivedistal end portion23,24 of theelongate member21,22 and the proximal aperture27a,28a. Thelumen29 allows for fluid or gaseous communication along the entire length of theelongate member21,22. In some embodiments, thedistal end portion23,24 may be configured to accept a Luer lock. In the embodiment shown inFIG. 3, a radial aperture29bmay be provided proximate theproximal end portion27,28 of the respectiveelongate member21,22 and provide a path for fluid or gas entering thelumen29 through the respective distal aperture23a,24ato leave thelumen29. Theradial aperture29ais configured to allow fluid or gas present within thelumen29 to leave theelongate member21,22 through theradial aperture29a.
• Theradial aperture29amay be defined within theproximal end portion27,28 of the respectiveelongate member21,22 such that the respective first orsecond end44,45 (144,145) of the brush portion40 (140) does not extend through thelumen29 far enough to block theradial aperture29a.
• A length ofsuture material88 is provided in combination with one or both of theelongate members21,22. Specifically, the length ofsuture material88 is threaded through adistal aperture25,26 defined through opposing side surfaces of theelongate member21,22 proximate to thedistal end portion23,24 of the respectiveelongate member21. In some embodiments, thedistal aperture25,26 extends through the entire cross-section of the respectiveelongate member21,22, while in embodiments where thelumen29 extends through the entire length of theelongate member21,22 thedistal aperture25,26 extends through opposing portions of the elongate member (i.e. those opposing portions defining the lumen29) and thelumen29. Regardless of the structure of thedistal aperture25,26 with respect to thelumen29 and the remainder of theelongate member21,22, thedistal aperture25,26 is configured to allow thesuture material88 to extend through theelongate member21,22 and therefore be retained by theelongate member21,22.
• Thesuture material88 includes two opposite ends that are tied together with a knot82 to form a loop80 after thesuture material88 is threaded through thedistal aperture25,26. The loop80 (and the length of thesuture material88 provided to form the loop80) is configured to such that a portion of the loop80 extends beyond the extreme distal end of theelongate member21,22. The loop80 is configured to receive animplantable material100 thereupon either directly or through a second suture180 that is tied to both the implantable material and the loop of thesuture material88. Theimplantable material100 is configured to be disposed and retained within the fistula to substantially block fluid or gaseous communication through the fistula between the rectum and the vagina, and provide a support structure or scaffold material for the patient's tissue to grow or redistribute thereupon to permanently block and close the fistula.
• A plug, chunk, length, or portion of animplantable material100 is provided and configured to be removeably connected to one or more suture loops80 by way of a second length of suture material180 that is tied to a portion of the implantable material. Several different suitable designs and structures for theimplantable material100 configured for use with the device10 are disclosed and described in U.S. Publication No. 2007/0198059, filed on Jan. 31, 2007, U.S. Provisional Application No. 60/947,573, filed on filed on Jul. 2, 2007, and U.S. Provisional Application No. 60/815,802, filed on Jun. 21, 2006 and subsequently filed as PCT Application No. PCT/US07/71798 on Jun. 21, 2207, which are each assigned to a subsidiary of the assignee of this application and the entirety of which are each fully incorporated by reference herein. The second suture material180 may be tied to the loop80 ofsuture material88 to connect theimplantable material100 to the device10.
• Theimplantable material100 may include an elongate portion104 that is of a length suitable for extending through a typical rectovaginal fistula, which is normally between approximately 5 mm and 10 mm but which may be smaller or larger depending on the patient's anatomy. In some embodiments, the elongate portion may be between about 5 and 10 cm in length, to provide an elongate portion104 of sufficient length to extend from the fistula after placement and allow the elongate portion104 to be sewn to the patient's vaginal mucosa for retention within the patient. The elongate portion104 of theimplantable device100 may be formed with a plurality of different diameters to be used with fistulae of different sizes and shapes, to allow the elongate portion104 to be inserted and drawn through the fistula tract while substantially enclosing the aperture between the rectum and the vagina defined by the fistula. The second suture material180 may be tied to adistal end106 of the elongate portion104, which is then tied to one of the loops80 on anelongate portion21,22 of the device10.
• Theimplantable device100 may additionally include a button110 that is fixed to a proximal end108 of the elongate portion104 with a suture material. The button110 may be substantially circular or formed with other circumferential shapes. The button110 provides a retention structure that does not fit within the fistula and a surface that is configured to be attached to the mucosa forming the rectal wall neighboring the fistula. The button110 may include one or more apertures112 (in some embodiments two or four apertures112) that provide suitable locations upon the button110 for the physician to sew to the rectal mucosa proximate the fistula. The button110 may be made from a substantially rigid implantable material such as plastic, or in other embodiments may be made from a biological material similar to that used to make the elongate portion104 as discussed below. In some embodiments, the button110 is not reabsorbed and separates from the elongate portion104 of theimplantable device100 after some time has elapsed after implantation due to the connection between the elongate portion104 and the rectal mucosa disintegrating.
• Theimplantable device100 is configured for ultimate placement within the fistula to promote tissue growth proximate and into the aperture defined by the fistula to close or occlude the fistula. The elongate portion104 of theimplantable material100 may be made from an extracellular matrix (ECM) material, such as submucosa, renal capsule membrane, dura mater, pericardium, serosa, peritoneum, or basement membrane. A preferred elongate portion104 may be submucosa, such as submucosa derived from a warm-blooded vertebrate. Mammalian submucosa materials are preferred. In particular, submucosa materials derived from animals raised for meat or other product production, e.g. pigs, cattle, or sheep, may be advantageous. Porcine submucosa provides a particularly preferred material, especially porcine small intestine submucosa (SIS), more especially porcine small intestine submucosa retaining substantially its native cross-linking.
• The submucosa or other ECM material can be derived from any suitable organ or other biological structure, including for example submucosa derived from the alimentary, respiratory, intestinal, urinary or genital tracts of warm-blooded vertebrates. Submucosa useful in the present invention can be obtained by harvesting such tissue sources and delaminating the submucosa from smooth muscle layers, mucosal layers, and/or other layers occurring in the tissue source.
• As prepared, the extracellular matrix material may optionally retain growth factors or other bioactive components native to the source tissue. For example, the matrix material may include one or more growth factors such as basic fibroblast growth factor (FGF-2), transforming growth factor beta (TGF-beta), epidermal growth factor (EGF), and/or platelet derived growth factor (PDGF). As well submucosa or other ECM material may include other biological materials such as heparin, heparin sulfate, hyaluronic acid, fibronectin and the like. Thus, generally speaking, the ECM material may include a bioactive component that induces, directly or indirectly, a cellular response such as a change in cell morphology, proliferation, growth, protein, or gene expression. Further, in addition or as an alternative to the inclusion of such native bioactive components, non-native bioactive components such as those synthetically produced by recombinant technology, or other methods, may be incorporated into the ECM material.
• ECM material used as the elongate portion104 of theimplantable material100 may be highly purified, for example, as described in U.S. Pat. No. 6,206,931, the disclosure thereof is fully incorporated by reference herein. For additional information concerning submucosa and its isolation, purification, and treatment, reference can be made, for example, to U.S. Pat. Nos. 4,902,508, 5,554,389, 5,993,844, 6,206,931, 6,099,567, and U.S. Published Application Nos. 2004/0180042, 2006/0201996, and 2007/0166395.
• The device10 is sized, shaped, and configured to be inserted into the patient to control and correct a rectovaginal fistula. In use the physician identifies one or more fistulae openings in one or both of the rectum or the vagina and inserts thedistal end portion23,24 of one of theelongate portions21,22 into the most convenient and accessible fistula opening (i.e. either inserted into the fistula from the rectal or the vaginal side of the fistula). The device10 is threaded through the fistula opening and navigated through the fistula wall until thedistal end portion23,24 of the leadingelongate portion21,22 extends out of the other of the openings in the rectum or vagina. Because the device is symmetrical about the brush portion40 (140) (i.e. the first and secondelongate portions21,22 are substantially the same), the physician may insert eitherelongate portion21,22 into either the rectal or vaginal fistula openings as convenient. The device10 then translated through the fistula until the brush portion40 (140) is proximate and extends through the fistula.
• The physician then reciprocatingly translates at least a portion of the brush portion40 (140) through the fistula in both directions to agitate or debride the inner circumferential surface of the fistula by contact between the plurality ofbristles42 of the brush portion40 and the fistula wall. The reciprocating agitation aids in the removal of any dead or unstable tissue therefrom to assist in the application, receipt, acceptance, and retention of the elongate portion104 of theimplantable material100 within the fistula. Specifically, the mechanical agitation of the inner surface of the fistula aids in the removal of any dead or unhealthy tissue bordering the fistula tract, which allow the elongate portion104 of theimplantable material100 to contact healthier tissue after insertion.
• After the fistula tissue is agitated or debrided, the fistula may be flushed with sterile saline or similar solutions to clean any fully or partially removed tissue from the fistula. In some embodiments, the fistula may additionally be flushed with a pharmacology active fluid to achieve a desired pharmacological response in the neighboring tissue, or a sclerosant or sealant to block a portion of the fistula if necessary. In other embodiments, the fistula tract may additionally be flushed with a liquid configured to aid in the removal of dead or damaged tissue defining the fistula tract. In some embodiments, the fistula is flushed by the physician with a bulb syringe or similar device that is positioned proximate to the most convenient opening of the fistula. In some embodiments such as the embodiment shown inFIG. 3, the fistula tract is flushed with fluid that flows through thelumen29 which one of theelongate members21,22 and enters the fistula (and leaves the device10) through aradial lumen29adisposed proximate the brush portion40 (140).
• After the physician has flushed the fistula and the circumferential tissue within the fistula, theimplantable material100 is affixed to the suture loop80 that extends through anaperture25,26 in theelongate member21,22 that extends from the patient's rectum. In some embodiments, a second suture180 is attached to adistal end106 of the elongate member104 of theimplantable material100. The opposite end of the second suture180 is tied to the loop80 on theelongate member21,22 that extends from the patient's rectum.
• The physician then with draws the device10 from the patient's vagina, which pulls the brush portion40 (140) from the fistula, and then pulls theelongate member21,22 that extended from the rectum through the fistula and eventually through the patient's vagina. As the device10 is fully withdrawn, the second suture180 still extends through the fistula (and the vagina and rectum). With the device10 further withdrawn from the patient, the implantable material eventually enters the rectum and then the fistula. Specifically, thedistal end106 of the elongate portion104 first enters the fistula, with a portion running fully through the fistula and entering the vagina.
• With continued tension on the second suture180, theimplantable material100 is fully drawn through the fistula tract until the button110 contacts the rectal mucosa proximate the fistula. The button110 is configured with a diameter substantially larger than the fistula to prevent the button110 from entering the fistula. When the physician feels the tension developed in the second suture180 as the button110 contacts the rectal mucosa proximate the fistula, the physician receives tactile notification that theimplantable material100, and specifically the elongate portion104 is properly positioned within the fistula tract. The physician then sews the button110 to the rectal mucosa, while maintaining traction upon the second suture180 (and therefore the elongate portion104 of the implantable material100), to retain the proper positioning of theimplantable material100 with respect to the rectal mucosa and the fistula. The physician places one or more stitches between the button110 and the rectal mucosa, and uses the one or more apertures112 in the button110, when provided.
• After fixing the button110 to the rectal mucosa, the physician next sews or otherwise fixes a portion of the elongate portion104 of theimplantable material100 extending from the fistula to the vaginal mucosa proximate the fistula with one or more sutures. After the elongate portion104 is fixed to the vaginal mucosa, any extra length of the elongate portion104 extending beyond the portion fixed to the vaginal mucosa and the second suture180 are each removed and discarded.
• While the preferred embodiments of the disclosure have been described, it should be understood that the invention is not so limited and modifications may be made without departing from the invention. The scope of the invention is defined by the appended claims, and all devices that come within the meaning of the claims, either literally or by equivalence, are intended to be embraced therein.

Claims (20)

1. A medical device comprising:

an elongate member extending between a first end portion and a second end portion;

a brush disposed upon the elongate member between the first end portion and the second end portion;

a first aperture disposed proximate the first end portion and a second aperture disposed proximate the second end portion;

a first suture disposed through the first aperture and tied upon itself to form a first loop, and a second suture disposed through the second aperture and tied upon itself to form a second loop, wherein each of the first loop and the second loop are configured to receive an implantable material.

2. The medical device ofclaim 1, wherein the elongate member is tubular and defines a lumen therethrough.

3. The medical device ofclaim 2, wherein the brush comprises a central portion with a plurality of radially extending bristles.

4. The medical device ofclaim 3, wherein the brush further comprises a wire with a central portion supporting the radially extending bristles and first and second extended ends disposed on opposite sides of the central portion that are each received within the lumen.

5. The medical device ofclaim 4, wherein the central wire comprises a plurality of wires twisted together along a length of the wire.

6. The medical device ofclaim 3, wherein the central portion is substantially shorter than each of the first end portion and the second end portion.

7. The medical device ofclaim 2, wherein the first end portion defines a first end and the second end portion defines a second end.

8. The medical device ofclaim 7, wherein one of the first end and the second end allows fluid communication with the lumen.

9. The medical device ofclaim 8, further comprising an aperture defined on a side surface of one of the first end portion or the second end portion.

10. The medical device ofclaim 7, wherein the first end and the second end are each substantially closed.

11. The medical device ofclaim 1, wherein the implantable material comprises a biomaterial.

12. The medical device ofclaim 11, wherein the biomaterial is SIS.

13. A medical device comprising:

an elongate member extending between a first end portion and a second end portion, the elongate member defining a lumen through at least a portion thereof;

a brush disposed upon the elongate member between the first end portion and the second end portion;

a first aperture defined in the first end portion and a second aperture defined in the second end portion;

a first suture disposed through the first aperture and tied to itself to define a first loop and a second suture disposed through the second aperture and tied to itself to define a second loop, wherein each of the first and second loops are configured to receive an implantable material.

14. The medical device ofclaim 13, wherein the brush comprises a central portion with a plurality of radially extending bristles and first and second ends disposed on opposite sides of the central portion that are each received with in the lumen.

15. The medical device ofclaim 14, wherein the brush further comprises a central wire that extends between the first and second ends and receives the plurality of radially extending bristles.

16. The medical device ofclaim 15, wherein the central wire comprises a plurality of wires woven together.

17. The medical device ofclaim 13, wherein the first end portion and the second end portion each extend substantially the same distance from the brush.

18. The medical device ofclaim 13, wherein the first end portion comprises a first end that includes a first end aperture that is configured to allow fluid communication with the lumen.

19. The medical device ofclaim 18, further comprising a radial aperture proximate the brush, the radial aperture in fluid communication with the lumen and the first end aperture.

20. The medical device ofclaim 13, wherein the elongate member is substantially flexible.

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